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The Submission Of A Section 513(G) Request For Information, Morgan Ashley Lano 2022 University of South Carolina

The Submission Of A Section 513(G) Request For Information, Morgan Ashley Lano

Theses and Dissertations

The Food and Drug Administration designates all medical devices into one of three general classes contingent on their intended use, indications for use, and potential risk to the user. This classification dictates the further path the device must take to be approved for the commercial market. Section 513(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(g)) is submitted in order to gain the agency’s unofficial classification and suggested regulatory requirements. The Coagulation Companion (MicroVide) is a device designed to fluorescently quantify a key enzyme involved in the coagulation cascade, plasmin, in pediatric patients. clot formation and degradation …


Biomechanical Analysis Of Athletes Sprinting With Varying Degrees Of Resistance, Michaela Ott 2022 University of Nebraska - Lincoln

Biomechanical Analysis Of Athletes Sprinting With Varying Degrees Of Resistance, Michaela Ott

Honors Program: Senior Projects (Public)

Utilizing resistance methods for sprinters is a common approach to their training. In this study, six athletes from the University of Nebraska-Lincoln Women’s Track and Field Team ran a series of sprints using a resistance machine to collect data regarding the change in power output, stride length, level of trunk tilt with respect to the ground, and acceleration throughout a distance of ten meters when different amounts of resistant forces were applied to the athlete. It was hypothesized that as resistance increased, power output would increase, stride length would decrease, the runners would become more horizontal resulting in a larger …


Process- And Product-Related Foulants In Virus Filtration, Solomon Isu, Xianghong Qian, Andrew L. Zydney, S. Ranil Wickramasinghe 2022 University of Arkansas, Fayetteville

Process- And Product-Related Foulants In Virus Filtration, Solomon Isu, Xianghong Qian, Andrew L. Zydney, S. Ranil Wickramasinghe

Biomedical Engineering Faculty Publications and Presentations

Regulatory authorities place stringent guidelines on the removal of contaminants during the manufacture of biopharmaceutical products. Monoclonal antibodies, Fc-fusion proteins, and other mammalian cell-derived biotherapeutics are heterogeneous molecules that are validated based on the production process and not on molecular homogeneity. Validation of clearance of potential contamination by viruses is a major challenge during the downstream purification of these therapeutics. Virus filtration is a single-use, size-based separation process in which the contaminating virus particles are retained while the therapeutic molecules pass through the membrane pores. Virus filtration is routinely used as part of the overall virus clearance strategy. Compromised performance …


Biomechanical And Psychological Predictors Of Failure In The Air Force Physical Fitness Test, Jeffrey Turner, Brent T. Langhals, Torrey J. Wagner 2022 Air Force Institute of Technology

Biomechanical And Psychological Predictors Of Failure In The Air Force Physical Fitness Test, Jeffrey Turner, Brent T. Langhals, Torrey J. Wagner

Faculty Publications

Physical fitness is a pillar of U.S. Air Force (USAF) readiness and ensures that Airmen can fulfill their assigned mission and be fit to deploy in any environment. The USAF assesses the fitness of service members on a periodic basis, and discharge can result from failed assessments. In this study, a 21-feature dataset was analyzed related to 223 active-duty Airmen who participated in a comprehensive mental and social health survey, body composition assessment, and physical performance battery. Graphical analysis revealed pass/fail trends related to body composition and obesity. Logistic regression and limited-capacity neural network algorithms were then applied to predict …


Macrophage-Targeted Anti-Ccl2 Immunotherapy Enhances Tumor Sensitivity To 5-Fluorouracil In A Balb/C-Ct26 Murine Colon Carcinoma Model Measured Using Diffuse Reflectance Spectroscopy, Shelby N. Bess, Gage J. Greening, Narasimhan Rajaram, Timothy J. Muldoon 2022 University of Arkansas, Fayetteville

Macrophage-Targeted Anti-Ccl2 Immunotherapy Enhances Tumor Sensitivity To 5-Fluorouracil In A Balb/C-Ct26 Murine Colon Carcinoma Model Measured Using Diffuse Reflectance Spectroscopy, Shelby N. Bess, Gage J. Greening, Narasimhan Rajaram, Timothy J. Muldoon

Biomedical Engineering Faculty Publications and Presentations

Background

Immunotherapy in colorectal cancer (CRC) regulates specific immune checkpoints and, when used in combination with chemotherapy, can improve patient prognosis. One specific immune checkpoint is the recruitment of circulating monocytes that differentiate into tumor-associated macrophages (TAMs) and promote tumor angiogenesis. Changes in vascularization can be non-invasively assessed via diffuse reflectance spectroscopy using hemoglobin concentrations and oxygenation in a localized tumor volume. In this study, we examine whether blockade of monocyte recruitment via CCL2 (macrophage chemoattractant protein-1) leads to enhanced sensitivity of 5-fluorouracil (5-FU) in a CT26-Balb/c mouse model of CRC. It was hypothesized that the blockade of TAMs will …


Finding Signal In The Noise: High-Fidelity, Quantitative, Optical Blood Perfusion Imaging With Interference, Abdul Mohaimen Safi 2022 University of South Florida

Finding Signal In The Noise: High-Fidelity, Quantitative, Optical Blood Perfusion Imaging With Interference, Abdul Mohaimen Safi

USF Tampa Graduate Theses and Dissertations

For label-free, non-invasive, wide field-of-view (FOV) imaging/monitoring of blood flow, speckle-based approaches are gaining popularity. However, to obtain quantitative flow information, speckle techniques rely on the multi-exposure scheme which requires complex, bulky, and expensive instrumentation, limiting its application to preclinical studies. This dissertation directly addresses these issues. In the first part of this dissertation, we report a novel single shot synthetic multi-exposure speckle imaging (syMESI) method to synthetically produce multi-exposure images from one short single exposure speckle image using spatial binning/averaging. We demonstrate that syMESI can reimagine conventional hardware based MESI, with low-cost single exposure laser speckle imaging (LSCI) instrumentation. …


Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar 2022 Harvard Law School

Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar

Other Publications

Medical devices have historically been less regulated than their drug and biologic counterparts. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety concerns. The Institute of Medicine in 2011 published a critique of the American pathway allowing moderate-risk devices to be brought to the market through the less-rigorous 501(k) pathway,1 flagging a need for increased postmarket review and surveillance. High-profile recalls of medical devices, such as vaginal mesh products, along with reports globally …


Synthesis Of Thiol-Acrylate Hydrogels For 3d Cell Culture And Microfluidic Applications, Anowar Hossain Khan 2022 Louisiana State University at Baton Rouge

Synthesis Of Thiol-Acrylate Hydrogels For 3d Cell Culture And Microfluidic Applications, Anowar Hossain Khan

LSU Doctoral Dissertations

Globally cell culture is an $18.98 billion industry as of 2020, with an 11.6 percent annual growth rate. Drug discovery has an estimated worth of $69.8 billion in 2020 and is predicted to grow to $110.4 billion by 2025. Three-dimensional (3D) cell culture of cancer cells is one of the rapidly growing felids since it better recapitulates in vivo conditions compared to two-dimensional (2D) models. However, it is challenging to grow 3D tumor spheroids outside the body, and some of the existing technology can generate these spheroids outside the human body but poorly mimic in vivo tumor models. Therefore, there …


Two-Stage Transfer Learning For Facial Expression Classification In Children, Gregory Hubbard, Megan Witherow, Khan Iftekharuddin 2022 Old Dominion University

Two-Stage Transfer Learning For Facial Expression Classification In Children, Gregory Hubbard, Megan Witherow, Khan Iftekharuddin

Undergraduate Research Symposium

Studying facial expressions can provide insight into the development of social skills in children and provide support to individuals with developmental disorders. In afflicted individuals, such as children with Autism Spectrum Disorder (ASD), atypical interpretations of facial expressions are well-documented. In computer vision, many popular and state-of-the-art deep learning architectures (VGG16, EfficientNet, ResNet, etc.) are readily available with pre-trained weights for general object recognition. Transfer learning utilizes these pre-trained models to improve generalization on a new task. In this project, transfer learning is implemented to leverage the pretrained model (general object recognition) on facial expression classification. Though this method, the …


Bayesian Network-Based Diagnostic Support Tool With Limited Point-Of-Care Ultrasound For Work-Related Elbow Injuries, Cristina Maria Franceschini Sánchez 2022 University of South Florida

Bayesian Network-Based Diagnostic Support Tool With Limited Point-Of-Care Ultrasound For Work-Related Elbow Injuries, Cristina Maria Franceschini Sánchez

USF Tampa Graduate Theses and Dissertations

The upper extremity is commonly injured at the workplace, frequently involving the elbow. Currently, there are not many diagnostic support tools for elbow injuries. Developing a clinical decision support tool would allow for narrowing differential diagnoses and guide management steps in a timely and cost-effective manner. In a descriptive retrospective cohort study, 85 non-contrast elbow MRIs were obtained from a large Workers Compensation insurer database. MRIs were either (a) greater than 2 weeks after first clinic visit, or (b) more than 6 weeks after injury, but (c) not more than 3 months after injury. A Bayesian network-based diagnostic support tool …


Protocol To Engineer Nanofilms Embedded Lipid Nanoparticles For Controlled And Targeted Drug Delivery (Nectar), Rashi Porwal, Stephen L. Hayward, Srivatsan Kidambi 2022 University of Nebraska-Lincoln

Protocol To Engineer Nanofilms Embedded Lipid Nanoparticles For Controlled And Targeted Drug Delivery (Nectar), Rashi Porwal, Stephen L. Hayward, Srivatsan Kidambi

Department of Chemical and Biomolecular Engineering: Faculty Publications

We present a protocol to engineer a substrate-mediated delivery platform comprising hyaluronic acid-coated lipid nanoparticles (HALNPs) embedded into polyelectrolyte multilayer (PEM) films. This platform allows controlled spatiotemporal release of lipid nanoparticles (LNP) by embedding them within the polyelectrolyte multilayer films matrix. HALNP conjugate with antibodies also adds the ability for targeted delivery. The use of LNP enables this platform to encapsulate both hydrophobic and hydrophilic drugs. This platform can easily be reproduced and utilized for various biomedical drug delivery applications. For complete details on the use and execution of this protocol, please refer to Hayward et al. (2015, 2016a, 2016b), …


Deep Learning Approach For Chemistry And Processing History Prediction From Materials Microstructure, Amir Abbas Kazemzadeh Farizhandi, Omar Betancourt, Mahmood Mamivand 2022 Boise State University

Deep Learning Approach For Chemistry And Processing History Prediction From Materials Microstructure, Amir Abbas Kazemzadeh Farizhandi, Omar Betancourt, Mahmood Mamivand

Mechanical and Biomedical Engineering Faculty Publications and Presentations

Finding the chemical composition and processing history from a microstructure morphology for heterogeneous materials is desired in many applications. While the simulation methods based on physical concepts such as the phase-field method can predict the spatio-temporal evolution of the materials’ microstructure, they are not efficient techniques for predicting processing and chemistry if a specific morphology is desired. In this study, we propose a framework based on a deep learning approach that enables us to predict the chemistry and processing history just by reading the morphological distribution of one element. As a case study, we used a dataset from spinodal decomposition …


Modeling Of Temperature Swing Adsorption-Oxidation Of Volatile Organic Compounds, Busuyi O. Adebayo, Fateme Rezaei 2022 Missouri University of Science and Technology

Modeling Of Temperature Swing Adsorption-Oxidation Of Volatile Organic Compounds, Busuyi O. Adebayo, Fateme Rezaei

Chemical and Biochemical Engineering Faculty Research & Creative Works

In this work, we simulated a single-bed 4-step temperature swing adsorption-oxidation (TSAO) process for capture and in situ oxidation of benzene, as a model VOC, over Ni/ZrO2-SiO2, as a dual-function material (DFM). The TSAO cycles consisted of adsorption, preheating, desorption/oxidation, and cooling steps. The model sensitive parameters were estimated via parameter estimation and validated against experimental data. Extensive parametric analysis was carried out to investigate the effects of key process variables on the TSAO performance. Model results revealed relatively good prediction of the process. Under the conditions investigated, adsorption, oxidation and total removal efficiencies were estimated …


Annealing Post-Drawn Polycaprolactone (Pcl) Nanofibers Optimizes Crystallinity And Molecular Alignment And Enhances Mechanical Properties And Drug Release Profiles, M. D. Flamini, T. Lima, K. Corkum, N. J. Alvarez, Vincent Beachley 2022 Rowan University

Annealing Post-Drawn Polycaprolactone (Pcl) Nanofibers Optimizes Crystallinity And Molecular Alignment And Enhances Mechanical Properties And Drug Release Profiles, M. D. Flamini, T. Lima, K. Corkum, N. J. Alvarez, Vincent Beachley

Henry M. Rowan College of Engineering Departmental Research

Post-drawn PCL nanofibers can be molecularly tuned to have a variety of mechanical properties and drug release profiles depending on the temperature and time of annealing, which has implications for regenerative medicine and drug delivery applications. Post-drawing polycaprolactone (PCL) nanofibers has previously been demonstrated to drastically increase their mechanical properties. Here the effects of annealing on post-drawn PCL nanofibers are characterized. It is shown that room temperature storage and in vivo temperatures increase crystallinity significantly on the order of weeks, and that high temperature annealing near melt significantly increases crystallinity and molecular orientation on the order of minutes. The kinetics …


Expanding Cherenkov Imaging Applications In Radiotherapy: Clinic-Wide In Vivo Treatment Monitoring And Mr-Linac Quality Assurance, Daniel A. Alexander 2022 Dartmouth College

Expanding Cherenkov Imaging Applications In Radiotherapy: Clinic-Wide In Vivo Treatment Monitoring And Mr-Linac Quality Assurance, Daniel A. Alexander

Dartmouth College Ph.D Dissertations

Radiation therapy treatments have become increasingly complex, striving to improve patient outcomes by delivering sufficient dose for tumor control while sparing more normal tissue. This trend has necessitated the development of additional workflows, such as multilayered incident mitigation strategies and advanced techniques for adapting treatments to account for time-sensitive patient factors. Novel technologies such as optical 3D surface monitoring and magnetic resonance-guided linear accelerators have been developed to assist clinicians in implementing these workflows. We hypothesize that optical imaging methods developed for radiotherapy dose monitoring and measurement can be used to positively impact modern radiation therapy challenges. Cherenkov imaging allows …


Optimization Of The Musculoskeletal Simulation In Estimation Of Metabolic Cost, Arash Mohammadzadeh Gonabadi, Philippe Malcolm 2022 University of Nebraska at Omaha

Optimization Of The Musculoskeletal Simulation In Estimation Of Metabolic Cost, Arash Mohammadzadeh Gonabadi, Philippe Malcolm

UNO Student Research and Creative Activity Fair

Energy from food is supplied to the human body in the form of chemical energy in the muscles. This metabolic energy expenditure is one of the main determinants of the way we walk, and indirect calorimetry measurements are an essential tool for understanding how increases in metabolic cost restrict the mobility of clinical populations. Respiratory oxygen consumption measurements allow recording of the average metabolic cost of walking. However, the time required for these measurements prevents assessing metabolic rate in patients who cannot walk long enough. Musculoskeletal modeling techniques allow to estimate average muscle energy expenditure during locomotion in conjunction with …


Reducing Loading On The Contralateral Limb Using Human-In-The-Loop Optimization, Siena Senatore 2022 University of Nebraska at Omaha

Reducing Loading On The Contralateral Limb Using Human-In-The-Loop Optimization, Siena Senatore

UNO Student Research and Creative Activity Fair

In most everyday activities, we head towards a specific goal by updating our choices for a more direct path. However, there are specific clinical tasks where taking the direct path is more challenging. Clinical investigations of optimizing a prosthesis involve the assessment of multiple parameter settings through trial and error rather than goal-directed optimization. We investigate if a human-in-the-loop optimization algorithm can guide manual alterations to a prosthesis-simulating device to reduce the ground reaction force on the contralateral limb. In most participants, the optimal condition reduced the loading rate on the contralateral limb compared to the initial condition tested. These …


How Can Actuation Timing And Magnitude Of A Bilateral Semi-Rigid Hip Exoskeleton Optimize Metabolic Cost, Arash Mohammadzadeh Gonabadi, Prokopios Antonellis, Sara Myers, Iraklis Pipinos, Philippe Malcolm 2022 University of Nebraska at Omaha

How Can Actuation Timing And Magnitude Of A Bilateral Semi-Rigid Hip Exoskeleton Optimize Metabolic Cost, Arash Mohammadzadeh Gonabadi, Prokopios Antonellis, Sara Myers, Iraklis Pipinos, Philippe Malcolm

UNO Student Research and Creative Activity Fair

Semi-rigid exoskeletons could combine some advantages of rigid and soft approaches. The purpose of this study was to investigate the effects of timing and magnitude of assistance from a semi-rigid hip exoskeleton. For ten participants, we tested ten conditions that were combinations of 5 different end-timings, ranging from 21% to 49%, and 2 different moment magnitudes ranging from 0.06 to 0.12 Nm.kg-1. The participants walked in two reference conditions: a condition without actuation and a condition without the exoskeleton. A semi-rigid hip exoskeleton could alter metabolic rate. However, to produce a net assistive effect, it is necessary to …


Changes In Ankle Muscle Force And Power During Walking In Patients With Peripheral Artery Disease, Hafizur Rahman, Cody Anderson, Iraklis I. Pipinos, Jason M. Johanning, Jianghu Dong, Sara A. Myers 2022 University of Nebraska at Omaha

Changes In Ankle Muscle Force And Power During Walking In Patients With Peripheral Artery Disease, Hafizur Rahman, Cody Anderson, Iraklis I. Pipinos, Jason M. Johanning, Jianghu Dong, Sara A. Myers

UNO Student Research and Creative Activity Fair

Background: Patients with peripheral artery disease (PAD) have significantly reduced lower extremity muscle strength compared with healthy individuals as measured during isolated, single plane joint motion by isometric and isokinetic strength dynamometers. The objective of this study was to understand the contribution of the ankle muscles during walking in patients with PAD and compared to healthy older individuals.

Methods: A total of 12 patients diagnosed with Fontaine stage II PAD and 10 healthy older controls were recruited for the study. Each subject walked across a 10-meter pathway with reflective markers placed on specific anatomical locations on lower limbs while the …


Design And Development Of Software With A Graphical User Interface To Display And Convert Multiple Microscopic Histology Images, Sayed Ahmadreza Razian, Majid Jadidi, ALEXEY KAMENSKIY 2022 University of Nebraska at Omaha

Design And Development Of Software With A Graphical User Interface To Display And Convert Multiple Microscopic Histology Images, Sayed Ahmadreza Razian, Majid Jadidi, Alexey Kamenskiy

UNO Student Research and Creative Activity Fair

Histological images are widely used to assess the microscopic anatomy of biological tissues. Recent advancements in image analysis allow the identification of structural features on histological sections that can help advance medical device development, brain and cancer research, drug discovery, vascular mechanobiology, and many other fields. Histological slide scanners create images in SVS and TIFF formats that were designed to archive image blocks and high-resolution textual information. Because these formats were primarily intended for storage, they are often not compatible with conventional image analysis software and require conversion before they can be used in research. We have developed a user-friendly …


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